- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377052
Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
A Phase II Study of Bortezomib and Gemcitabine in Patients With Relapsed Mantle Cell Lymphoma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression and duration of response in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- QEII Health Sciences Center
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Halifax, Nova Scotia, Canada, B3H 1V7
- QEII, CCR, Hematology Research
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Univ. Health Network-Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University - Dept. Oncology
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma
- Relapsed disease
Not refractory to prior therapy
- Must have received 1-3 prior systemic chemotherapy regimens AND has had no disease progression while receiving chemotherapy or within 1 month of last dose of most recent therapy
Clinically and/or radiologically documented disease
At least 1 site of disease must be bidimensionally measurable by CT scan or MRI with ≥ 1 lesion meeting 1 of the following criteria:
- Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan
- Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam
- No nonmeasurable disease only
- No preexisting ascites or pleural effusion ≥ grade 2
- No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST or ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF ≥ 45% by echocardiogram or MUGA
- No history of allergic reactions attributed to compounds containing boron or mannitol
- No preexisting edema ≥ grade 2
- No preexisting neuropathy (sensory and/or pain) ≥ grade 2
- No preexisting shortness of breath ≥ grade 2
- No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
No other serious illness or medical condition that would preclude compliance with study requirements, including any of the following:
- Serious uncontrolled infection
Uncontrolled or severe cardiovascular disease, including any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class III-IV heart failure
- Uncontrolled angina
- Clinically significant pericardial disease
- Cardiac amyloidosis
- Significant neurological disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy
- No prior radioactive monoclonal antibody therapy
- No prior bortezomib
- No prior investigational therapy (except for flavopiridol)
- No prior radiotherapy to > 25% of functioning bone marrow
At least 4 weeks since prior radiotherapy and recovered
- Low-dose, nonmyelosuppressive radiotherapy may be allowed
- At least 2 weeks since prior major surgery
- No other concurrent anticancer therapy
- No concurrent corticosteroids
- No other concurrent cytotoxic chemotherapy
- No other concurrent investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Bortezomib + Gemcitabine
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1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective tumor response (overall response rate with 95% confidence interval)
Time Frame: each cycle
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each cycle
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Time to progression at median time
Time Frame: each cycle and every 3 months after treatment
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each cycle and every 3 months after treatment
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Duration of response (median and range)
Time Frame: each cycle and every 3 months after treatment
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each cycle and every 3 months after treatment
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Rate of stable disease and progressive disease
Time Frame: each cycle and every 3 months after treatment
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each cycle and every 3 months after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: C. Tom Kouroukis, MD, Margaret and Charles Juravinski Cancer Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Bortezomib
- Gemcitabine
Other Study ID Numbers
- I172
- CAN-NCIC-IND172 (Registry Identifier: PDQ)
- ORTHO-CAN-NCIC-IND172 (Other Identifier: Ortho Biotech)
- CDR0000493021 (Other Identifier: PDQ)
- B9E-CA-0485 (Other Identifier: Lilly)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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